DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the axial extension of each of the plurality of axially projecting arms, of the outer cuff, being approximately half a length of the at least one cell in a stretched condition (claim 6), each of the plurality of axially projecting arms, of the outer cuff, being approximately equal in length to the at least one cell in a stretched condition (claim 7), each of the plurality of axially projecting arms, of the outer cuff, being approximately greater in length to the at least one cell in a relaxed condition (claims 8 and 10), and each of the plurality of axially projecting arms, of the outer cuff, being approximately shorter in length to the at least one cell in a stretched condition (claim 9) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 6, 7 and 9, which recite the term “approximately”, on the 2nd line of each claim, this term is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, the claims also recite the term “a stretched condition”, on the last line of each claim; however, this term is found to be confusing since it is not clear what exactly, structurally, is meant by said term. Specifically, stretched compared to what and/or stretched in what way, i.e. stretched to a compressed configuration, or stretched to an expanded configuration, or stretched in some other way; thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, thereby rendering the claims indefinite.
Regarding claims 8 and 10, which recite the term “approximately”, on the 2nd line of both claims, this term is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, the claims also recite the term “a relaxed condition”, on the last line each claim; however, this term is found to be confusing since it is not clear what exactly, structurally, is meant by said term. Specifically, relaxed compared to what and/or relaxed in what way, i.e. relaxed to a compressed configuration, or relaxed to an expanded configuration, or relaxed in some other way; thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention, thereby rendering the claims indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims, such as claims 1-13, only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Morin et al. (US PG Pub. 2018/0055631), hereinafter Morin, in view of Braido et al. (US PG Pub. 2011/0098802), hereinafter Braido.
Regarding claim 1, Morin discloses a prosthetic heart valve, illustrated in Figures 17A and 18A, comprising a collapsible and expandable stent (802) having a plurality of cells (812) including a lowermost row of cells; a valve including an inner cuff (806), and a plurality of leaflets secured to the stent (802); and an outer cuff (850) at least partially covering the lowermost row of cells (812), the outer cuff having a bottom edge (852), a top edge (862), and a plurality of axially projecting arms (860) extending from the top edge (862), the outer cuff (850) being attached to at least one cell at a bottom vertex to form at least one parachute, and to an upper vertex (S1a) of the at least one cell via at least one of the plurality of axially projecting arms (860), illustrated in Figures 17A and 18A ([0045]; [0048], Lines 1-10; [0104] & [0105]); but does not specifically disclose the outer cuff is attached to at least two side vertices.
However, Braido discloses a prosthetic heart valve, in the same field of endeavor, comprising an outer cuff (285) which is attached to at least one cell, of the stent, at two side vertices and a bottom vertex to form at least one parachute/pocket (220), illustrated in Figure 10, there can be any number and/or size of the pockets, which can be adjusted by the amounts/location of the attachment points at side vertices of the cells of the stent ([0070]).
In view of the teachings of Braido, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the outer cuff, of the prosthetic heart valve of Morin, to be attached to at least one cell of the stent at two side vertices, in addition to the bottom, in order to create multiple parachute/pocket portions and/or adjust their size, in order to be more patient specific to fill gaps formed between a native valve annulus and the prosthetic heart valve.
Regarding claim 2, Morin in view of Braido disclose the prosthetic heart valve according to claim 1, wherein Morin further teaches the lowermost row of cells (812) includes a first quantity of cells, and the plurality of axially projecting arms (860) includes a first quantity of arms equal to the first quantity of cells, illustrated in Figure 17A (Morin: [0105]).
Regarding claim 3, Morin in view of Braido disclose the prosthetic heart valve according to claim 2, wherein Morin further teaches the lowermost row of cells (812) includes nine cells, and the plurality of axially projecting arms (860) includes nine arms, illustrated in Figure 17A.
Regarding claim 4, Morin in view of Braido disclose the prosthetic heart valve according to claim 1, and though it is not specifically disclosed that each of the plurality of axially projecting arms is T-shaped, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate shape/form for the plurality of axially projecting arms, including them having a T-shape, since doing so amounts to a mere change in shape/form, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). Furthermore, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of each of the plurality of axially projecting arms being T-shaped, as opposed to having any other shape/form.
Regarding claim 5, Morin in view of Braido disclose the prosthetic heart valve according to claim 1, wherein Morin further teaches each of the plurality of axially projecting arms (860) includes an axial extension (H1 of arms 860) and a transverse terminal end, illustrated in Figures 17A and 18A (to clarify, the terminal end at S1a, of each projecting arm 860, has a width, thereby constituting a transverse end).
Regarding claims 6, 7 and 9, Morin in view of Braido disclose the prosthetic heart valve according to claim 5, and though it is not specifically disclosed that the axial extension of each of the plurality of axially projecting arms is approximately half a length of, or equal in length to, or shorter in length to, the at least one cell when the at least one cell is in a stretched condition, these parameters are deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate length/size for the plurality of axially projecting arms, including half a length of, or equal in length to, or shorter in length to, the at least one cell when the at least one cell is in a stretched condition, since doing so amounts to a mere modification in size/proportion of a known component, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Also, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the plurality of axially projecting arms being approximately half a length of, or equal in length to, or shorter in length to, the at least one cell when the at least one cell is in a stretched condition, as opposed to having any other size/length.
Regarding claims 8 and 10, Morin in view of Braido disclose the prosthetic heart valve according to claims 7 and 9, and though it is not specifically disclosed that each of the plurality of axially projecting arms is approximately greater in length to the at least one cell when the at least one cell is in a relaxed condition, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate length/size for the plurality of axially projecting arms, including approximately greater in length to the at least one cell in a relaxed condition, since doing so amounts to a mere modification in size/proportion of a known component, which is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04). Furthermore, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameters of the plurality of axially projecting arms being approximately greater in length to the at least one cell when the at least one cell is in a relaxed condition, as opposed to having any other size/length.
Regarding claim 11, Morin in view of Braido disclose the prosthetic heart valve according to claim 5, wherein Morin further teaches the transverse terminal end (end at S1a of each projecting arm 860) is coupled to the upper vertex of the at least one cell (812) via a suture, illustrated in Figures 17A and 18A (Morin: [0105]).
Regarding claim 12, Morin in view of Braido disclose the prosthetic heart valve according to claim , wherein Morin further teaches the terminal end (end at S1a of each projecting arm 860) is attached/coupled to the upper vertex of the at least one cell (812), illustrated in Figures 17A and 18A (Morin: [0105]); and though it is not specifically disclosed that the transverse terminal end is attached/coupled by wrapped around the upper vertex of the at least one cell, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate way of attaching/coupling the transverse terminal end to the upper vertex of the at least one cell, including by wrapped around, since doing so amounts to a mere modification in art equivalent means of attaching/coupling. Moreover, it is to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the transverse terminal end being wrapped around the upper vertex of the at least one cell, as opposed to being attached/coupled by any other means/way.
Regarding claim 14, Morin discloses a method of loading a prosthetic heart valve, illustrated in Figures 17A, 17B, 18A and 18B, comprising providing a collapsible and expandable stent (802) having a plurality of cells (812) including a lowermost row of cells, a valve including an inner cuff (806), and a plurality of leaflets secured to the stent (802), and an outer cuff (850) at least partially covering the lowermost row of cells (812), the outer cuff having a bottom edge (852), a top edge (862), and a plurality of axially projecting arms (860) extending from the top edge (862), the outer cuff (850) being attached to at least one cell at a bottom vertex to form at least one parachute, and to an upper vertex (S1a) of the at least one cell via at least one of the plurality of axially projecting arms (860), illustrated in Figures 17A, 17B, 18A and 18B; axially stretching/collapsing the stent so that the plurality of projecting arms gathers the outer cuff closer to the stent; and loading the prosthetic heart valve into a delivery device ([0045]; [0048], Lines 1-10; [0050]; [0104]; [0105]; [0107] & [0108]); but does not specifically disclose the outer cuff is attached to at least two side vertices.
However, Braido discloses a prosthetic heart valve, in the same field of endeavor, comprising an outer cuff (285) which is attached to at least one cell, of the stent, at two side vertices and a bottom vertex to form at least one parachute/pocket (220), illustrated in Figure 10, there can be any number and/or size of the pockets, which can be adjusted by the amounts/location of the attachment points at side vertices of the cells of the stent ([0070]).
In view of the teachings of Braido, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the outer cuff, of the prosthetic heart valve of the method of loading the prosthetic heart valve of Morin, to be attached to at least one cell of the stent at two side vertices, in addition to the bottom, in order to create multiple parachute/pocket portions and/or adjust their size, in order to be more patient specific to fill gaps formed between a native valve annulus and the prosthetic heart valve.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Morin in view of Braido as applied to claim 1 above, and further in view of Li et al. (US PG Pub. 2014/0107772), hereinafter Li.
Regarding claim 13, Morin in view of Braido disclose the prosthetic heart valve according to claim 1, but does not specifically teach the outer cuff includes a plurality of spaced notches along the bottom edge, wherein each of the plurality of axially projecting arms is aligned with one of the plurality of spaced notches.
However, Li teaches a prosthetic heart valve, in the same field of endeavor, comprising a cuff (250) which includes a plurality of spaced notches (265) along the bottom edge, illustrated in Figure 4, the notches allow for the removal of as much unused cuff material as possible in order to reduce bulk during compression and delivery ([0039]).
In view of the teachings of Li, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the bottom edge of the outer cuff, of the prosthetic heart valve of Morin in view of Braido, to include a plurality of spaced notches such that each of the plurality of axially projecting arms is aligned with one of the plurality of spaced notches; the notches allowing for the removal of as much unused cuff material as possible in order to reduce bulk during compression and delivery, as taught by Li.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/13/2026
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